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Glytone Acne Clearing Cleanser

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This product has been discontinued

Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
April 29, 2024
Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
April 29, 2024
Manufacturer
Pierre Fabre USA
Registration number
M006
NDC root
64760-705

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Drug Overview

GLYTONE is an acne clearing cleanser designed to help you manage and reduce acne breakouts. It contains 2% salicylic acid, which works by penetrating your pores to eliminate most acne blemishes, including blackheads and whiteheads. This cleanser not only dries and clears existing blemishes but also helps prevent the formation of new ones, allowing your skin to heal effectively.

With a volume of 200 mL (6.7 fl. oz.), GLYTONE is formulated to support your skincare routine by targeting acne and promoting clearer skin.

Uses

If you're dealing with acne, this treatment can be a helpful option for you. It works by drying and clearing acne blemishes, which allows your skin to heal more effectively.

The formula penetrates deep into your pores to target and eliminate most types of acne blemishes, including blackheads and whiteheads. Additionally, it helps prevent the formation of new blemishes, ensuring that your skin stays clearer for longer.

Dosage and Administration

To use this medication effectively, start by dispensing a small amount into your hand and mixing it with a little water. Once mixed, apply a thin layer over the entire affected area using a circular motion. After application, rinse the area thoroughly with warm water. You should do this twice a day.

However, to avoid excessive drying of your skin, it’s best to begin with just one application each day. If your skin tolerates it well, you can gradually increase to two applications daily, unless your doctor advises otherwise. If you experience bothersome dryness or peeling, reduce your application to once a day or even every other day to help your skin adjust.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you experience a rash, you should stop using the product and consult your doctor for further guidance. Additionally, make sure to avoid contact with your eyes; if the product does get into your eyes, rinse them thoroughly with water to prevent irritation.

While there are no specific contraindications or concerns regarding controlled substances, abuse, or dependence associated with this medication, it's always best to use it responsibly and as directed. Your health and safety are paramount, so don't hesitate to reach out to a healthcare professional if you have any questions or concerns.

Side Effects

This product is for external use only. While using it, you may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. To minimize irritation, it’s best to use only one topical acne treatment at a time. Be careful to avoid contact with your eyes; if this happens, rinse your eyes thoroughly with water.

You should stop using the product and consult a doctor if you develop a rash. Additionally, keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas other than your skin. If you are using another topical acne medication, be cautious, as using both at the same time can increase the risk of skin irritation and dryness. If you experience any irritation, it’s best to stop using one of the products.

Make sure to keep the product away from your eyes. If it accidentally gets into your eyes, rinse them thoroughly with water. If you notice a rash while using this product, stop using it and consult your doctor.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical when taking the medication as prescribed.

Always err on the side of caution. If you suspect an overdose, don’t wait for symptoms to appear—reach out for help right away. Your safety is the top priority, and medical professionals are equipped to provide the necessary assistance.

Pregnancy Use

When it comes to using Glytone Acne Clearing Cleanser during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this product on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this cleanser or any new skincare products. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can use Glytone Acne Clearing Cleanser without specific warnings or recommendations. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your nursing infant. As always, if you have concerns about any products you use while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

When using Glytone Acne Clearing Cleanser, there is no specific information available about its use in older adults. This means that the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions that might be necessary for elderly patients.

If you are an older adult or a caregiver, it’s important to consult with a healthcare professional before starting any new treatment. They can help ensure that the product is appropriate for your needs and discuss any potential risks or considerations based on your health status.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using multiple acne treatments at once. If you use another topical acne medication alongside this one, you may experience increased skin irritation and dryness. To minimize these side effects, it's best to use only one topical acne medication at a time.

Always discuss your current medications and any new treatments with your healthcare provider. They can help you understand the best approach for your skin care routine and ensure that you avoid any unnecessary discomfort.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68-77°F (20-25°C). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so with clean hands and in a safe environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is GLYTONE?

GLYTONE is an acne clearing cleanser designed to dry and clear acne blemishes while allowing the skin to heal.

What is the active ingredient in GLYTONE?

GLYTONE contains 2% Salicylic Acid, which helps penetrate pores to eliminate most acne blemishes, blackheads, and whiteheads.

How should I use GLYTONE?

Dispense a small amount into your hand, mix with a little water, and apply a thin layer over the affected area in a circular motion. Rinse thoroughly with warm water two times daily.

What should I do if I experience dryness or irritation?

If you experience bothersome dryness or peeling, reduce application to once a day or every other day.

Are there any warnings associated with GLYTONE?

GLYTONE is for external use only. Avoid contact with eyes, and if eye contact occurs, rinse thoroughly with water.

What should I do if a rash occurs?

Stop use and ask a doctor if a rash occurs.

How should I store GLYTONE?

Store GLYTONE at room temperature between 68-77°F (20-25°C).

Is GLYTONE safe for use during pregnancy or while nursing?

There is no specific information regarding the use of GLYTONE during pregnancy or nursing, so consult your doctor for advice.

What should I do if GLYTONE is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use other topical acne medications with GLYTONE?

Using another topical acne medication at the same time may increase the likelihood of skin irritation and dryness. It's best to use only one at a time.

Packaging Info

Below are the non-prescription pack sizes of Glytone Acne Clearing Cleanser (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Glytone Acne Clearing Cleanser.
Details

Drug Information (PDF)

This file contains official product information for Glytone Acne Clearing Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

GLYTONE is an acne clearing cleanser formulated with 2% salicylic acid. It is presented in a liquid dosage form, with a volume of 200 mL (6.7 fl. oz.). The product is designed to assist in the treatment of acne through its active ingredient, salicylic acid, which is known for its exfoliating properties and ability to penetrate pores.

Uses and Indications

This drug is indicated for the treatment of acne vulgaris. It effectively dries and clears acne blemishes, facilitating the healing process of the skin. The formulation penetrates pores to eliminate most acne blemishes, including blackheads and whiteheads. Additionally, it aids in the prevention of the development of new acne blemishes, blackheads, and whiteheads.

Limitations of Use: This drug is intended for use in individuals with mild to moderate acne. It is not recommended for the treatment of severe acne or for use in patients with hypersensitivity to any of the ingredients.

Dosage and Administration

Healthcare professionals are advised to dispense a small amount of the product into the hand and mix it with a little water prior to application. A thin layer should be applied over the entire affected area using a circular motion. The area should then be rinsed thoroughly with warm water.

Initially, it is recommended to start with one application daily to minimize the risk of excessive drying of the skin. If tolerated, the frequency may be gradually increased to two times daily, or as directed by a physician. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day.

Contraindications

Use of this product is contraindicated in patients who develop a rash during treatment; discontinuation and consultation with a healthcare professional are advised. Additionally, contact with the eyes should be avoided. In the event of eye contact, it is essential to rinse thoroughly with water.

Warnings and Precautions

For external use only.

Skin irritation and dryness may be exacerbated when used concurrently with other topical acne medications. It is advised that only one topical acne medication be utilized at a time to minimize the risk of irritation. Healthcare professionals should instruct patients to avoid contact with the eyes; in the event of accidental eye contact, it is imperative to rinse thoroughly with water.

Patients should be advised to discontinue use and consult a physician if a rash develops.

In cases of ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. The most common adverse reactions reported include skin irritation and dryness, particularly when used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised that patients use only one topical acne medication at a time.

In the event of eye contact, patients should rinse thoroughly with water to mitigate potential adverse effects. Additionally, if a rash occurs, patients are instructed to stop use and consult a healthcare professional.

It is crucial to keep this product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of one of the medications should be considered to alleviate symptoms. Monitoring for signs of skin irritation is recommended when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Glytone Acne Clearing Cleanser (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Glytone Acne Clearing Cleanser.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of Glytone Acne Clearing Cleanser in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when recommending this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

There is no information available regarding the use of Glytone Acne Clearing Cleanser during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits of using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Glytone Acne Clearing Cleanser in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if a rash occurs. It is important to discuss that while using this product, skin irritation and dryness may be more likely if they are using another topical acne medication concurrently. Therefore, patients should be encouraged to use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. In the event of eye contact, patients should be instructed to rinse thoroughly with water.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 68-77° F (20-25° C) to ensure its stability and efficacy. Proper storage conditions must be adhered to, as deviations from the recommended temperature range may compromise the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Glytone Acne Clearing Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Glytone Acne Clearing Cleanser, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.